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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS PRISMATIC; LAMP, SURGICAL

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MAQUET SAS PRISMATIC; LAMP, SURGICAL Back to Search Results
Catalog Number ARD567027999
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Event Description
On (b)(6) 2022 getinge became aware of an issue with one of our surgical lights - prismatic.As it was stated, the label of the device was missing.No injury was reported due to mentioned issue, however, we decided to report this case in abundance of caution as label falling off into sterile field or during procedure may cause contamination.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
 
Manufacturer Narrative
The correction of d4 serial # deems required.This is based on the internal evaluation.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Getinge became aware of an issue with one of our surgical lights - prismatic.As it was stated, serial number was missing from the label.No injury was reported due to mentioned issue, however, we decided to report this case in abundance of caution as label falling off into sterile field or during procedure may cause contamination.Further information provided by getinge technician indicated that serial number wore off and it was no longer visible on the identification label.It was established that when the event occurred, the surgical light did not meet its specification due to serial number missing from device¿s label, which contributed to the event.Based on additional input from getinge technician it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of peeling off or missing particles of the label, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.It is not likely that the issue could lead to the serious injury or death when the malfunction reoccurs.That is why it is not considered to be safety related and reportable.As stated by subject matter expert at manufacturer¿s, the serial number from the label came off probably due to excessive friction during cleaning or inappropriate cleaning products and hard knocks which could cause scratches, chips and other damages.Maintenance instructions are always included in user manual delivered with each maquet sas device.Therefore, the most probable root cause of such an issue is improper use.We believe the related devices are performing correctly in the market.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
 
Event Description
Manufacturer reference number (b)(4).
 
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Brand Name
PRISMATIC
Type of Device
LAMP, SURGICAL
Manufacturer (Section G)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer Contact
pascal jay
parc de limere
avenue de la pomme de pin
ardon 
MDR Report Key13786627
MDR Text Key287587233
Report Number9710055-2022-00076
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberARD567027999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/15/2022
Initial Date FDA Received03/16/2022
Supplement Dates Manufacturer Received03/21/2022
Supplement Dates FDA Received04/11/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/13/1997
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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